Application 090194

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	20MG/10ML (2MG/ML)	No	No
002	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	150MG/30ML (5MG/ML)	No	No
003	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	150MG/20ML (7.5MG/ML)	No	No
004	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	100MG/10ML (10MG/ML)	No	No
005	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	40MG/20ML (2MG/ML)	No	No
006	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	200MG/20ML (10MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A090194-001	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	20MG/10ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23
A090194-002	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	2014-09-23
A090194-003	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	2014-09-23
A090194-004	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23
A090194-005	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23
A090194-006	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090194-001	ROPIVACAINE HYDROCHLORIDE	20MG/10ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090194-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	2014-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090194-003	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	2014-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090194-004	ROPIVACAINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090194-005	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090194-006	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090194-001	ROPIVACAINE HYDROCHLORIDE	20MG/10ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090194-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	2014-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090194-003	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	2014-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090194-004	ROPIVACAINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090194-005	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090194-006	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090194-001	ROPIVACAINE HYDROCHLORIDE	20MG/10ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090194-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	2014-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090194-003	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	2014-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090194-004	ROPIVACAINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090194-005	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090194-006	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090194-001	ROPIVACAINE HYDROCHLORIDE	20MG/10ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090194-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	2014-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090194-003	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	2014-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090194-004	ROPIVACAINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090194-005	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090194-006	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090194-001	ROPIVACAINE HYDROCHLORIDE	20MG/10ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090194-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	2014-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090194-003	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	2014-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090194-004	ROPIVACAINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090194-005	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090194-006	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090194-001	ROPIVACAINE HYDROCHLORIDE	20MG/10ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090194-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	2014-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090194-003	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	2014-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090194-004	ROPIVACAINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090194-005	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090194-006	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090194-001	ROPIVACAINE HYDROCHLORIDE	20MG/10ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090194-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	2014-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090194-003	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	2014-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090194-004	ROPIVACAINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 162 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A090194-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090194-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090194-003	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090194-004	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090194-005	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090194-006	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090194-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090194-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090194-003	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090194-004	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090194-005	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090194-006	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090194-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090194-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090194-003	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090194-004	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090194-005	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090194-006	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090194-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090194-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090194-003	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090194-004	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090194-005	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090194-006	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090194-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090194-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090194-003	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090194-004	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090194-005	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090194-006	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090194-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090194-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090194-003	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090194-004	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090194-005	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090194-006	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090194-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090194-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090194-003	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090194-004	AP	1	`782e0a99824c…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	dff4a1e4-4b2a-4a64-b6d8-ea470dee88f7	2024-08-15	Warnings, Adverse reactions	Name fallback generic name: ROPIVACAINE HYDROCHLORIDE
Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	23d2d448-a744-4877-9f2d-7e57c198da89	2024-08-06	Warnings, Adverse reactions	Name fallback generic name: ROPIVACAINE HYDROCHLORIDE
Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	c6613708-c1f7-4f5c-91a3-ebbc1d7905c6	2024-07-10	Warnings, Adverse reactions	Name fallback generic name: ROPIVACAINE HYDROCHLORIDE
Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	56dfabf7-f7a8-4601-b17a-cb16fb995b0f	2024-05-22	Warnings, Adverse reactions	Name fallback generic name: ROPIVACAINE HYDROCHLORIDE
Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	da1ce22b-6a8e-40a2-afbb-011fa3ed3a8b	2024-04-18	Warnings, Adverse reactions	Name fallback brand name: Ropivacaine Hydrochloride generic name: ROPIVACAINE HYDROCHLORIDE
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	Baxter Healthcare Corporation	e057aeb2-5125-490c-b691-847426fd42d0	2023-10-10	Warnings, Adverse reactions	Name fallback brand name: ROPIVACAINE HYDROCHLORIDE generic name: ROPIVACAINE HYDROCHLORIDE
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	Baxter Healthcare Corporation	781d4b7f-7556-4695-8d48-7772d7a0d8e9	2023-06-28	Warnings, Adverse reactions	Name fallback brand name: ROPIVACAINE HYDROCHLORIDE generic name: ROPIVACAINE HYDROCHLORIDE
Ropivacaine hydrochloride	ROPIVACAINE HYDROCHLORIDE	Gland Pharma Limited	643c1729-096e-459c-80c1-78b78e698da6	2022-08-22	Warnings, Adverse reactions	Name fallback brand name: Ropivacaine hydrochloride generic name: ROPIVACAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-9300	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9300	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9300	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9300	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9300	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9301	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9301	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9301	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9301	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9301	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9302	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9302	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9302	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9302	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9302	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9303	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9303	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9303	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9303	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9303	Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current